[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491217":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":42,"studyPopulation":30,"armGroups":43,"interventions":61,"overallOfficials":77,"centralContacts":81,"locations":87,"responsibleParty":103,"collaborators":106,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":30,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":30,"enrollmentInfo":120,"targetDuration":30,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":30,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"University of Arizona","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in depression features","The difference in the change in depression features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.","Change from baseline depression to 8 weeks after the start of intervention",{"measure":14,"description":15,"timeFrame":16},"Change in anxiety features","The difference in the change in anxiety features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.","Change from baseline anxiety to 8 weeks after the start of intervention",[18,21,24,27],{"measure":10,"description":19,"timeFrame":20},"The difference in the change in depression features between the intervention arms from before to 12 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.","Change from baseline depression to 12 weeks after the start of intervention",{"measure":14,"description":22,"timeFrame":23},"The difference in the change in anxiety features between the intervention arms from before to 12 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.","Change from baseline anxiety to 12 weeks after the start of intervention",{"measure":10,"description":25,"timeFrame":26},"The difference in the change in depression features between the intervention arms from before to 32 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.","Change from baseline depression to 32 weeks after the start of intervention",{"measure":14,"description":28,"timeFrame":29},"The difference in the change in anxiety features between the intervention arms from before to 32 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.","Change from baseline anxiety to 32 weeks after the start of intervention",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","randomized clinical trial design","SUPPORTIVE_CARE",{"masking":37,"maskingDescription":38,"whoMasked":39},"DOUBLE","Participants will be informed of their group assignment only after completion of the baseline (T1) assessment, and data collectors will be blinded to study group assignment for all future assessments. Participants will be asked to not discuss their group assignment with anyone other than the study coordinator. The PI and other investigators will be blinded to arm assignment.",[40,41],"INVESTIGATOR","OUTCOMES_ASSESSOR","The goal of this project is to determine if CBCT (Cognitively-Based Compassion Training) can reduce distress for survivors compared to an attention control (Health Education; HE) when delivered by Zoom to both survivors and caregivers\u002F supportive partners as a dyad (i.e., CBCT for dyads; CBCT-D). We will also test whether instructing survivors and caregivers\u002F supportive partners together in CBCT (CBCT-D) reduces distress more than when survivors receive CBCT instruction by themselves, without caregivers\u002F supportive partners (i.e., CBCT for survivors; CBCT-S). The following specific aims address these questions:\n\nAim 1: Determine if survivors and caregivers\u002F supportive partners exhibit less depression and anxiety (primary outcomes) when survivors receive online CBCT along with their informal caregiver\u002F\u002F supportive partner (CBCT-D), compared to when survivors receive online CBCT alone (CBCT-S) or when survivors and informal caregivers\u002F\u002F supportive partners receive online HE. We will recruit dyads (N=226) consisting of survivors (between 3 months and 5 years post treatments with curative intent, i.e., chemotherapy, radiation, surgery) and their caregivers\u002F supportive partners. H1: Survivors and caregivers randomized to CBCT-D will exhibit greater improvements in distress (i.e., depression, anxiety; primary outcomes in survivors) at months 2, 3, and 8 versus those randomized to CBCT-S or HE.\n\nAim 2: Test the extent to which reductions in survivor's depression and anxiety from online CBCT-D are mediated by social connection, dyadic function, and caregiver\u002F supportive partner distress. H2a: Survivor's social connection and dyadic function will mediate the effects of online CBCT-D versus HE on survivor's distress at months 2, 3 and 8. H2b: Caregiver's social connection, dyadic function, and distress will mediate the effects of CBCT-D versus CBCT-S or HE on survivor's distress.\n\nAim 3: Explore the effects of online CBCT-D versus CBCT-S and HE on survivor diurnal cortisol rhythm at months 2, 3 and 8, and the extent to which cortisol rhythm is a marker versus mediator of improvements in survivor's distress at month 2, 3, and 8.",[44,50,55],{"label":45,"type":46,"description":47,"interventionNames":48},"Cognitively-Based Compassion Training for Survivors (CBCT-S)","EXPERIMENTAL","CBCT-S is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-S will be administered to breast cancer survivors and will not including supportive partners.\n\nModule 1 (Week 1): Overview and Connecting to A Moment of Nurturance\n\nModule 2 (Week 2) Developing Stable and Clear Attention\n\nModule 3 (Week 3): Enhancing Self Awareness\n\nModule 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering\n\nModule 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering.\n\nModule 6(Week 6): Expanding our Circle of Concern\n\nModule 7 (Week 7): Deepening Gratitude and Tenderness\n\nModule 8 (Week 8): Harnessing the Power of Compassion",[49],"Behavioral: Cognitively-Based Compassion Training for Survivors",{"label":51,"type":46,"description":52,"interventionNames":53},"Cognitively-Based Compassion Training for Dyads (CBCT-D)","CBCT-D is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-D will be administered to breast cancer survivors and supportive partners together.\n\nModule 1 (Week 1): Overview and Connecting to A Moment of Nurturance\n\nModule 2 (Week 2) Developing Stable and Clear Attention\n\nModule 3 (Week 3): Enhancing Self Awareness\n\nModule 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering\n\nModule 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering.\n\nModule 6(Week 6): Expanding our Circle of Concern\n\nModule 7 (Week 7): Deepening Gratitude and Tenderness\n\nModule 8 (Week 8): Harnessing the Power of Compassion",[54],"Behavioral: Cognitively-Based Compassion Training for Dyads",{"label":56,"type":57,"description":58,"interventionNames":59},"Health Education","ACTIVE_COMPARATOR","HE focuses on topics relevant to health and cancer, but is also intended for individuals who are not cancer survivors themselves.\n\nHE will be administered to both breast cancer survivors and supportive partners together.\n\nModule I (Week 1): Cancer Advocacy.\n\nModule II (Week 2): Health Through the Lifespan.\n\nModule III (Week 3): Nutrition.\n\nModule III (Week 4): Nutrition.\n\nModule IV (Week 5): Physical Activity.\n\nModule V (Week 6): Sleep.\n\nModule VI (Week 7): Stress.\n\nModule VII (Week 8): Mental Health and Social Support.",[60],"Behavioral: Health Education",[62,68,73],{"type":63,"name":64,"description":47,"armGroupLabels":65,"otherNames":66},"BEHAVIORAL","Cognitively-Based Compassion Training for Survivors",[45],[67],"CBCT-S",{"type":63,"name":69,"description":52,"armGroupLabels":70,"otherNames":71},"Cognitively-Based Compassion Training for Dyads",[51],[72],"CBCT-D",{"type":63,"name":56,"description":58,"armGroupLabels":74,"otherNames":75},[56],[76],"HE",[78],{"name":79,"affiliation":5,"role":80},"Thaddeus Pace, PhD","PRINCIPAL_INVESTIGATOR",[82],{"name":83,"role":84,"phone":85,"phoneExt":30,"email":86},"Jacquelyn Martin","CONTACT","520-621-1930","UArizona-SUPORT@email.arizona.edu",[88],{"facility":5,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"RECRUITING","Tucson","Arizona","85721","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-110.92648,32.22174,{"lat":99,"lon":98},[102],{"name":83,"role":84,"phone":85,"phoneExt":30,"email":86},{"type":80,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Thaddeus Pace","Associate Professor of Nursing, Psychiatry, and Psychology",[107],{"name":108,"class":109},"National Cancer Institute (NCI)","NIH","100491217","phase-2-the-breast-cancer-survivors-and-partners-online-research-together-suport-project-100491217",false,"NCT05676255","The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project","The SUPORT Project: Leveraging Social Connection by Including Informal Caregivers in an Internet Video Conference-based Compassion Meditation Intervention to Reduce Psychological Distress in Breast Cancer Survivors","Breast cancer survivors:\n\nInclusion Criteria:\n\n* biological sex: woman\n* able to speak and understand English\n* have a diagnosis of a breast cancer\n* have completed primary curative cancer treatments (i.e., surgery, radiation, chemotherapy) except for hormonal therapies (e.g., aromatase inhibitors) or trastuzumab a minimum of 3 months and a maximum of 5 years before starting CBCT or the control\n* have a supportive partner (aka caregiver) who can participate with them\n\nExclusion Criteria:\n\n* nursing home resident\n* have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions \\[completed or attempted\\] per year, either with a group or individually, to be evaluated by the Principal Investigator)\n\nSupportive partners (aka informal caregivers)\n\nInclusion Criteria:\n\n* named by the survivor\n* live in the same household as the survivor\n* able to speak and understand English\n\nExclusion Criteria:\n\n* have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions \\[completed or attempted\\] per year, either with a group or individually, to be evaluated by the Principal Investigator)",true,"ALL","18 Years",{"count":121,"type":122},452,"ESTIMATED","INTERVENTIONAL",[125],"PHASE2","Many breast cancer survivors (estimated 70% in some studies) experience clinically significant depression and\u002For anxiety in the months and years after finishing cancer treatments. This research will build on the rigor of prior research to reduce breast cancer survivor depression and anxiety with a compassion meditation intervention called CBCT (Cognitively-Based Compassion Training) for online synchronous delivery that is also inclusive of informal caregivers (i.e., adult family members who live with and typically provide half the care for survivors, aka supportive partners).",[128,129],"Breast Cancer Female","Psychological Distress","2026-10-05",{"date":132,"type":133},"2026-10-08","ACTUAL",{"date":135,"type":133},"2023-03-20",{"date":137,"type":122},"2027-06",{"name":5,"class":6},1]